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Clinical Research Specialist

  • Contract
  • Anywhere

Website TalentBurst, Inc.

TalentBurst, Inc.

Company : TalentBurst, Inc.

Country: United States

Location : Irvine, California

Post: Wed, 15 Sep 2021 01:10:29 GMT

Expires: Wed, 03 Nov 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Position: Clinical Research Specialist, Req#:
Location: Irvine, CA (Local candidates needed to work onsite – about 50% onsite right now and will increase as further reintegration occurs.
Duration: 12+ Months Contract
Job Description:
Education and Experience:

* Bachelor’s Degree in a related field, 3 years of previous experience with regulatory documentation for clinical studies Required
* Experience in Site monitoring, site qualification, and site training Preferred
* Experience in cardiac research Preferred
* Sponsor experience with clinical trial operations/research Preferred
* Experience in Medical device trial Preferred
* Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) Required
* Excellent written and verbal communication skills and interpersonal relationship skills
* Excellent problem-solving and critical thinking skills
* Solid knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
* Solid understanding of regulatory submissions, reporting, and audits
* Ability to manage confidential information with discretion
* Strict attention to detail
* Ability to interact professionally with all organizational levels
* Ability to manage competing priorities in a fast-paced environment
* Must be able to work in a team environment, including inter-departmental teams, and representing the organization on specific projects
* Ability to build productive internal/external working relationships
* Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control Key Responsibilities:
* Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements
* Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study-specific essential document lists, managing and communicating the status of study progress and activities
* Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
* Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
* Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
* Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews, and resolution
* Other incidental duties #LI-FRESH

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